Drug-Disease Interaction in Crohn's Disease

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01261286
First received: December 14, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.

Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a surrogate marker of sympathetic nervous activity, will be similar between the healthy patients and the CD patients; the sympathetic nervous system of the heart will be similar to healthy patients; Crohn's disease patients with normal CRP will have higher drug response compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have higher verapamil response than those with similar symptom profiles who are not infliximab treated.


Condition Intervention Phase
Crohn's Disease
Drug: verapamil
Phase 1

Study Type: Interventional
Official Title: Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients

Resource links provided by NLM:


Further study details as provided by University of Alberta:

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willingness to adhere the study protocol
  • Males of females of non-childbearing potential aged from 18 to 65 years
  • Lab values no more than 10% outside of the lab's stated normal range unless the subject is in the Crohn's disease group and the values are related to the disease, or if the PI decides the abnormality is not clinically significant
  • The subject is healthy (except for the Crohn's disease group)
  • Non-smoker for at least 3 months

Exclusion Criteria:

  • History of hypersensitivity to verapamil
  • Significant history of gastrointestinal (other than Crohn's disease), liver, kidney, or any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • Significant history of allergies
  • Significant history of cardiovascular or hematological disease
  • Significant history of asthma, chronic bronchitis or bronchospastic conditions
  • Presence of diabetes mellitus or any other condition which would preclude fasting
  • Maintenance therapy with any drug (except those prescribed for Crohn's disease) or a history of drug dependence, alcohol abuse, or serious psychological disease
  • Any clinically significant illness other than Crohn's disease in the previous 30 days prior to the study
  • Use of enzyme-modifying drugs in the previous 30 days before the study
  • Blood donation in the previous 56 days or multiple blood samplings in the previous 30 days before the study
  • History of fainting upon blood sampling
  • Participation in another clinical trial within 30 days of the study
  • Narcotic use
  • Glucocorticoid treatment in the last 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261286

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Richard Fedorak, MD University of Alberta
  More Information

No publications provided

Responsible Party: Dr. Richard Fedorak, University of Alberta
ClinicalTrials.gov Identifier: NCT01261286     History of Changes
Other Study ID Numbers: VER-2010
Study First Received: December 14, 2010
Last Updated: December 14, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
inflammation
receptor downregulation
reduced response
calcium channels
PK-PD relationship

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Verapamil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014